[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6151 Introduced in House (IH)]







110th CONGRESS
  2d Session
                                H. R. 6151

To amend the Federal Food, Drug, and Cosmetic Act with respect to drug 
            and device advertising, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 22, 2008

  Ms. DeLauro (for herself and Mrs. Emerson) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act with respect to drug 
            and device advertising, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Responsibility in Drug and Device 
Advertising Act of 2008''.

SEC. 2. DIRECT-TO-CONSUMER DRUG OR DEVICE ADVERTISING.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended--
            (1) in section 301, by adding at the end the following:
    ``(oo) The conduct of direct-to-consumer advertising of a drug or 
device in violation of section 503C.''; and
            (2) in chapter V, by inserting after section 503B the 
        following:

``SEC. 503C. DIRECT-TO-CONSUMER DRUG OR DEVICE ADVERTISING.

    ``(a) Prohibitions.--
            ``(1) First three years.--
                    ``(A) In general.--Subject to subparagraph (B), no 
                person shall conduct direct-to-consumer advertising 
                of--
                            ``(i) a drug for which an application is 
                        submitted under section 505(b) before the end 
                        of the 3-year period beginning on the date of 
                        the approval of such application; or
                            ``(ii) a class II or class III device for 
                        which a premarket notification is submitted 
                        under section 510(k) or a class III device for 
                        which a premarket approval is sought under 
                        section 515, before the end of the 3-year 
                        period beginning on the date of the 
                        notification or approval, respectively.
                    ``(B) Waiver.--The Secretary may waive the 
                application of subparagraph (A) to a drug or device 
                during the third year of the 3-year period described in 
                such subparagraph if--
                            ``(i) the sponsor of the drug or device 
                        submits an application to the Secretary 
                        pursuant to subparagraph (C); and
                            ``(ii) the Secretary, after considering the 
                        application and any accompanying materials, 
                        determines that direct-to-consumer advertising 
                        of the drug or device would have an affirmative 
                        value to public health.
                    ``(C) Application for waiver.--To seek a waiver 
                under subparagraph (B), the sponsor of a drug or device 
                shall submit an application to the Secretary at such 
                time, in such manner, and containing such information 
                as the Secretary may require.
            ``(2) Subsequent years.--
                    ``(A) Extension of prohibition.--The Secretary may 
                prohibit direct-to-consumer advertising of a drug or a 
                class II or class III device during the period 
                beginning at the end of the 3-year period described in 
                paragraph (1)(A) if the Secretary determines that the 
                drug or device has significant adverse health effects 
                based on post-approval studies, risk-benefit analyses, 
                adverse event reports, the scientific literature, any 
                clinical or observational studies, or any other 
                appropriate resource.
                    ``(B) Fair balance of benefits and risks for drugs 
                and devices for permitted dtc advertising.--Any direct-
                to-consumer advertising of a drug or a class II or 
                class III device permitted under this section shall 
                include a fair balance, as supported by the evidence, 
                of the benefits and the risks associated with the drug 
                or device.
    ``(b) Regulations.--Not later than 1 year after the date of the 
enactment of this section, the Secretary shall revise the regulations 
promulgated under this Act governing advertisements of drugs and 
devices to the extent necessary to implement this section.
    ``(c) Rule of Construction.--This section shall not be construed to 
diminish the authority of the Secretary to prohibit or regulate direct-
to-consumer advertising of drugs or devices under other provisions of 
law.''.
    (b) Effective Date.--The amendments made by subsection (a) apply 
only with respect to a drug for which an application is approved under 
section 505(b) of the Federal Food, Drug, and Cosmetic Act, a class II 
or class III device for which a notification is submitted under section 
510(k) of such Act, or a class III device for which an application is 
approved under section 515 of such Act, on or after the date that is 1 
year before the date of the enactment of this Act.

SEC. 3. PROMINENT DISPLAY OF INFORMATION IN ADVERTISING ON SIDE 
              EFFECTS, CONTRAINDICATIONS, AND EFFECTIVENESS.

    (a) Requirement for Drugs.--
            (1) In general.--Subparagraph (3) of section 502(n) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is 
        amended--
                    (A) by striking ``such other information'' and all 
                that follows through ``which shall be issued by'' and 
                inserting ``such other information in brief summary 
                relating to side effects, contraindications, and 
                effectiveness as shall be required in regulations which 
                shall require such information to be prominently 
                displayed in terms of font size and location and shall 
                be issued by'';
                    (B) by striking ``in the case of published direct-
                to-consumer advertisements'' and inserting ``in the 
                case of direct-to-consumer advertisements (including an 
                advertisement that accompanies video programming 
                delivered by television broadcasting or by a 
                multichannel video programming distributor (as defined 
                in section 602 of the Communications Act of 1934))''; 
                and
                    (C) by striking ``published after the effective 
                date'' and inserting ``disseminated after the effective 
                date''.
            (2) Discontinuance of study.--The Secretary of Health and 
        Human Services shall discontinue the study required by section 
        906(b) of the Food and Drug Administration Amendments Act of 
        2007 (Public Law 110-85).
    (b) Application of Similar Rules for Devices.--The first sentence 
of section 502(r) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352(r)) is amended--
            (1) by striking ``(1) a true statement'' and inserting ``a 
        true statement (1)'';
            (2) by striking ``a brief statement''; and
            (3) by inserting before the period at the end the 
        following: ``, and in the case of direct-to-consumer 
        advertisements (including an advertisement that accompanies 
        video programming delivered by television broadcasting or by a 
        multichannel video programming distributor (as defined in 
        section 602 of the Communications Act of 1934)) the following 
        statement printed in conspicuous text: `You are encouraged to 
        report negative side effects of medical devices to the FDA. 
        Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.'''.
    (c) Effective Date.--The amendments made by this section apply with 
respect to any advertisement or other descriptive printed matter that 
is issued or caused to be issued on or after the date that is 90 days 
after the date of the enactment of this Act. Not later than 90 days 
after the date of the enactment of this Act, the Secretary shall revise 
any regulations promulgated pursuant to subsections (n) and (r) of 
section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) 
to the extent necessary to implement this section.

SEC. 4. CIVIL PENALTY.

    Subsection (g) of section 303 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333) is amended to read as follows:
    ``(g) Drug or Device Advertising and Promotion.--
            ``(1) Civil penalty.--
                    ``(A) In general.--Any manufacturer, packer, or 
                distributor of a drug or device who violates section 
                505(n), section 503C, or any other requirement of this 
                Act relating to the advertising or promotion of the 
                drug or device shall be subject to a civil penalty in 
                an amount not to exceed--
                            ``(i) in the case of the first such 
                        violation by the manufacturer, packer, or 
                        distributor relating to the drug or device, 
                        $1,000,000; and
                            ``(ii) in the case of each subsequent 
                        violation by the manufacturer, packer, or 
                        distributor relating to the drug or device, an 
                        amount that is twice the amount of the maximum 
                        civil penalty applicable under this 
                        subparagraph to the previous violation.
                    ``(B) Procedure.--Paragraphs (3) through (5) of 
                subsection (f) shall apply with respect to a civil 
                penalty under subparagraph (A) to the same extent and 
                in the same manner as those paragraphs apply with 
                respect to a civil penalty under paragraph (1), (2), 
                (3), or (4) of subsection (f).
            ``(2) Distribution of materials.--If the Secretary finds 
        that a person committed a violation described in paragraph 
        (1)(A), the Secretary may order the person to distribute 
        materials in the same markets in which the violative 
        advertisement or promotional material was distributed in a 
        manner designed to notify the public and the medical community 
        of the violation and to provide corrective information.
            ``(3) Separate offense.--For purposes of imposing a civil 
        penalty under this subsection, each violation described in 
        paragraph (1)(A), including each distribution of a direct-to-
        consumer advertisement in violation of section 503C, shall 
        constitute a separate offense.
            ``(4) Relation to other penalties.--A civil penalty under 
        paragraph (1) and an order under paragraph (2) shall be in 
        addition to any other penalty applicable under this Act or 
        other law to the violation involved.''.

SEC. 5. PUBLIC EDUCATION CAMPAIGN ON RISKS OF CERTAIN DRUGS AND 
              DEVICES.

    The Secretary of Health and Human Services shall conduct an 
education campaign to increase public awareness of risks that, for some 
patients, may outweigh the benefits of using a particular drug or 
device, whether such risks are known at the time of the approval of the 
drug or device or become known after the approval of the drug or 
device.

SEC. 6. ADDITIONAL FUNDING FOR REGULATION OF DIRECT-TO-CONSUMER DRUG 
              AND DEVICE ADVERTISING.

    There are authorized to be appropriated to the Food and Drug 
Administration such sums as may be necessary for each of fiscal years 
2009 and 2010 for the purpose of regulating direct-to-consumer drug and 
device advertisements, including by carrying out the amendments made by 
section 2. The authorization of appropriations in the preceding 
sentence is in addition to any other authorization of appropriations 
for such purpose.
                                 <all>